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New Limits and Procedures for Elemental Impurities in Pharmaceuticals and Dietary Supplements

By Jeff Grindstaff and Colleen Schroeder

Changes to USP heavy metal testing procedures for the analysis of pharmaceuticals and dietary supplements are under review with new standards set to be in place by mid-2013.4 Heavy metals, which can be found in medicine, occur naturally in the ecosystem with large variations in concentration. Heavy metal can include elements lighter than carbon and can exclude some of the heaviest metals. The point of the review is to update current analytical testing historically performed using United States Pharmacopeia (USP) <231>. The revisions (USP<232>, USP<233>, and USP<2232>) are designed to set more safe limits for public exposure and to lower the environmental impact from dated methods. Many in the pharmaceutical industry have concerns about the new equipment, more strict requirements, and the accompanied costs. Nonetheless, the changes should have a positive impact on the industry by improving specificity and analyte recoveries, as well as by yielding overall time savings resulting in more safe, high quality products.

Changes to the elemental impurities test will mean a serious change for the pharmaceutical business. The revision will shift the analyses from a relatively cheap procedure that requires little set-up and operator training to tests that require expensive equipment and professional metals analysts. However, by employing modern instrumental methods, the USP’s intent is to ensure safer products for the people as well as offer flexibility and efficiency during analysis.